Drugs

Development and Regulation of Abuse-Deterrent Opioid Medications; Public Meeting

On October 30 and 31, 2014, FDA will host a public meeting at the Sheraton, Silver Spring, MD to discuss the development, assessment, and regulation of abuse-deterrent formulations of opioid medications. The meeting will focus on scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA’s approach towards assessing the benefits and risks of all opioid medications, including those with abuse-deterrent properties. On August 29, 2014, FDA held individual telecons with the brand name and generic industries to discuss industry participation in this meeting. The transcripts from those calls are attached. The January, 2013 draft guidance for Industry - Abuse Deterrent Opioids – Evaluation and Labeling is also attached.

Registration is now closed because the room is filled to capacity. No more registrations or walk in attendees will be accepted. See Public Meeting: Abuse-Deterrent (AD) Formulation. Attendees must register by October 24, 2014. Those wishing to participate in the Open Public Hearing must register by October 14, 2014. The docket will be open for written comments until January 9. 2015.